Manager / Senior Manager Engineering

RESPONSIBILITIES

• Manage and lead the engineering department at the site, ensuring smooth operations.
• Oversee operation and maintenance of HVAC systems and utilities.
• Develop, implement, and monitor monthly planners and maintenance schedules.
• Ensure readiness of the department for customer and regulatory audits; represent the department during audits.
• Implement corrective and preventive actions (CAPA) and monitor their effectiveness.
• Monitor and ensure compliance with process equipment and facility maintenance activities in line with cGMP requirements.
• Maintain and control all engineering documentation required for regulatory audits.
• Ensure compliance with all statutory and regulatory requirements related to the engineering department.
• Manage qualification, validation, and CSV validation activities.
• Manage change control, deviations, QRM, and all QMS-related documentation.
• Drive implementation of cGMP, GDP, Good Engineering Practices, and Learning Management Systems.
• Manage external vendors and contractors with proper work planning, supervision, and monitoring of activities.
• Prepare, review, and approve SOPs and engineering drawings.
• Prepare and monitor the engineering budget, including expenditure under various budget heads and site projects.
• Propose and implement improvement and cost-saving plans for management approval.
• Identify departmental training needs, ensure trainings are conducted as per schedule, and oversee allocation of roles, jobs, and responsibilities to team members and contract staff.

DESIRED SKILLS

• Experience of handling engineering in a reputed pharmaceutical organization
• Hands on experience in handling Utility (Chiller, air compressor, air dryers, boiler) HVAC
• Experience in handling statutory requirements
• Experience in facing regulatory audits, especially USFDA.
• Good technical know-how and exposure to latest technology and process equipment
• Ability to pivot and try new approaches when faced with challenges.
• Very good communication (written and oral), interpersonal and conflict resolution skills.
• Leadership, mentoring and team building skills.
• Ability to work on multiple projects in various stages.
• Personnel and project management skills.